Pioglitazone for Idiopathic Gastroparesis

NCT04300127 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB00184232
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The principal objective of this pilot study will be to evaluate whether 8 weeks of treatment of pioglitazone will improve symptoms as measured by the Gastrointestinal Symptom Index (GCSI) in patients with Idiopathic Gastroparesis.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Severity of Gastrointestinal Symptoms as Assessed by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index

  The effect of Pioglitazone on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index (GCSI) which has been designed to assess symptoms associated with gastroparesis. Symptoms are rated as none (0), mild (1), moderate (2), severe (3), very severe (4) scale of the worst severity of the symptom over the last 24 hours. Values reported represent the mean participant scale choice.

  Baseline, later monthly up to 3 months.

Secondary Outcomes (6)

• Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)

  Baseline and later monthly up to 3 months

• Functional Status as Assessed by the SF-36v2 Health Survey

  Baseline, later monthly up to 3 months

• C- Reactive Protein Level in Blood

  Baseline and 2 months after treatment initiation.

• Erythrocyte Sedimentation Rate (ESR)

  Baseline and 2 months after treatment initiation

• Mood as Assessed by the Beck Depression Inventory

  Baseline, later monthly up to 3 months

Study Arms (1)

Pioglitazone

EXPERIMENTAL

Candidates who after the screening period are eligible to receive Pioglitazone

Drug: Pioglitazone 30 mg

Interventions

Pioglitazone 30 mg DRUG

Patients will received 30 mg of Pioglitazone once a day for 8 weeks

Pioglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older at registration
• Diagnosis of gastroparesis as documented by gastric emptying scintigraphy (4-hour emptying after a low-fat meal with any combination of 2 and 4 hour retention of \>60% and 10% respectively)
• Ongoing symptoms referable to gastroparesis (i.e. Nausea and vomiting, bloating, and abdominal pain)
• Females will be required to use adequate contraceptive methods during study participation as determined by the Principal Investigator and the study team members

You may not qualify if:

• Another active disorder, which could explain symptoms in the opinion of the investigator
• Age \< than 18 years
• Pregnancy or nursing
• Previous surgery of the upper gastrointestinal tract, including vagotomy
• Another active disorder, which could explain symptoms in the opinion of the investigator
• Use of narcotics more than 3 days per week
• Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2 x upper limit of normal (ULN) or a Child-Pugh score of 10 or greater
• Serious systemic disease, such as recent myocardial infarction/unstable angina, decompensated congestive heart failure, severe pulmonary disease with dyspnea at rest, or altered mental status from any cause
• Diabetes as defined by HbA1c \>6.5 and/or fasting blood sugar of \>125 mg/DL
• Contraindications to pioglitazone such as hypersensitivity or allergy
• Concurrent use of: estradiol, ethynyl estradiol, mestranol, pazopanib, warfarin, digoxin, atorvastatin, ranitidine, gemfibrozil, fexofenadine, midazolam
• Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
• History of bladder cancer or family history of bladder cancer
• Failure to give informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jay Pasricha
• Organization: Mayo Clinic Arizona

pasricha.jay@mayo.edu

(480)301-4279

Study Officials

• Glenn J Treisman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: October 24, 2019
• Primary Completion: March 15, 2025
• Study Completion: March 18, 2025
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)